Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease

Sedentary Lifestyle Clinical Trial

Official title:

Randomized Control Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905929
• Other study ID #: 160682
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: March 30, 2022

Study information

• Verified date: October 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA) Women's Health Program will assess 3-month changes in sitting time, standing time, physical activity and blood pressure in a randomized control trial (RCT). This 2-arm RCT will occur in the community with post menopausal Latina women (N=250) who spend at least 8 hrs/day sitting and have increased risk for cardiovascular disease through high BMI and other cardiometabolic risk factors. Women will be identified through the San Ysidro Health Center and assessed at the South Bay Latino Research Center.

Description:

Project 2 will address the following aims:

1. Investigate the 3 month effect of the intervention to impact the primary behavioral outcomes of sitting, standing and stepping time assessed objectively by a thigh worn inclinometer (ActivPAL) in Latinas at risk for heart disease.

2. Investigate the 3 month effect of the intervention to impact the secondary health outcomes of blood pressure, depressive symptoms, and anthropometrics.

3. Explore the psychosocial & environmental mediators & moderators of changes in sitting time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: March 30, 2022
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion criteria for RCT (n=250):

1. Postmenopausal woman, no menstruation for at least 1 year, 55+ years of age.

2. Self-identify as Hispanic ethnicity, able to read and write in English or Spanish,

3. Ambulatory, medically stable, able to give informed consent, and safely complete the protocols.

4. Body Mass Index range of 25.0-45.0kg/m2.

5. Sedentary: Average >8 hours sitting/day, as measured by ActivPAL on 4+ days per week

6. Phone access (to receive counseling)

Prisoners will not be used for this study.

Exclusion criteria applicable only to the RCT intervention trial participants include:

1. Unable to complete the Short Physical Performance Battery.

2. Mental states that would preclude complete understanding of the protocol and compliance.

3. Active cancer or another serious chronic illness that may be associated with weight change

4. Body Mass Index <25.0 or >45.0kg/m2.

5. Use of insulin medications.

6. = 8hr average daily sitting time, as measured by ActivPAL.

7. Participating in another clinical trial related to study outcomes (as determined by the PI).

8. Unable to wear devices

Related Conditions & MeSH terms

• Heart Diseases
• Sedentary Lifestyle

Intervention

Device:
• ActivPAL inclinometer
Participants will wear a thigh-worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. The device will monitor their sitting and standing time.

Behavioral:
• Phone counseling call: Breaking up sitting time
Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.
• In-person counseling: Breaking up sitting time
Participants will receive 3 in-person health education sessions. At these sessions participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. Participants will also develop action plans, check-in on goal setting, and use of tools at these sessions.
• Phone counseling call: Healthy living
Participants will receive a healthy living educational intervention over the phone, developed and tested by the investigators in previous studies. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.

Other:
• Tools to prompt standing
Investigators will provide standing desks to participants who spend time sitting at a computer. Additional tools to help prompt standing are mechanical and electronic timers set to interrupt long periods of sitting and cues in the environment such as standing during commercial breaks and phone calls.

Behavioral:
• In-person counseling: Healthy living
Control subjects will receive one in-person counseling session about healthy living. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.

Locations

Country	Name	City	State
United States	South Bay Latino Research Center	Chula Vista	California
United States	UCSD	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego State University, San Ysidro Health Center, South Bay Latino Research Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84. — View Citation

Gardiner PA. Understanding and influencing sedentary behaviour in older adults [dissertation]. Vol Doctorate of Philosophy. Brisbane, Australia: University of Queeensland; 2011.

Norman G, Vaughn AA, Roesch S, Sallis JF, Calfas K, Patrick K. Development of decisional balance and self-efficacy measures for adolescent sedentary behaviors. Psychology and Health 2004;19:561-575.

Norman GJ, Sallis JF, Gaskins R. Comparability and reliability of paper- and computer-based measures of psychosocial constructs for adolescent physical activity and sedentary behaviors. Res Q Exerc Sport. 2005 Sep;76(3):315-23. — View Citation

Rosenberg DE, Sallis JF, Kerr J, Maher J, Norman GJ, Durant N, Harris SK, Saelens BE. Brief scales to assess physical activity and sedentary equipment in the home. Int J Behav Nutr Phys Act. 2010 Jan 31;7:10. doi: 10.1186/1479-5868-7-10. — View Citation

Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. — View Citation

Salmon J, Hume C, Ball K, Booth M, Crawford D. Individual, social and home environment determinants of change in children's television viewing: the Switch-Play intervention. J Sci Med Sport. 2006 Oct;9(5):378-87. Epub 2006 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mitochondrial functioning biomarkers	Targeted metabolomic measurement of ~300 plasma metabolites (e.g., amino acids, acylcarnitines, organic acids), primarily associated with mitochondrial biochemical pathways	3 months
Other	Epigenetic DNA modification profile	Measurement of DNA methylation in peripheral blood monocytes (PBMCs) to determine "bio-age" and Apparent Methylomic Aging Rate (AMAR)	3 months
Other	Epigenetic microRNA biomarkers	Measurement of microRNA populations in blood (PBMCs and endothelial cell microparticles) using Hi-Seq	3 months
Other	Vascular environment/endothelial functioning biomarker 1	Measurement of plasma biomarkers of systemic inflammation (C-reactive protein (CRP))	3 months
Other	Vascular environment/endothelial functioning biomarker 2	Measurement of endothelial cell adhesiveness and activation (vascular adhesion molecule 1 (sVCAM-1))	3 months
Other	Vascular environment/endothelial functioning biomarker 3	Measurement of endothelial cell adhesiveness and activation (intercellular adhesion molecule 1 (sICAM-1))	3 months
Other	Vascular environment/endothelial functioning biomarker 4	Measurement of endothelial cell adhesiveness and activation (P- and E-selectins)	3 months
Other	Vascular environment/endothelial functioning biomarker 5	Measurement of oxidative stress (F2-isoprostane)	3 months
Other	Vascular environment/endothelial functioning biomarker 6	Measurement of coagulation (fibrinogen)	3 months
Other	Glucoregulatory and lipid metabolism biomarker 1	Measurement of fasting plasma insulin	3 months
Other	Glucoregulatory and lipid metabolism biomarker 2	Measurement of glucose	3 months
Other	Glucoregulatory and lipid metabolism biomarker 3	Measurement of lipid panel components (total cholesterol, LDL, HDL and triglycerides)	3 months
Other	Glucoregulatory and lipid metabolism biomarker 4	Measurement of hemoglobin A1c (HbA1c)	3 months
Primary	Sitting, standing and stepping time	Change in daily time spent sitting, standing and stepping during waking hours as measured objectively by the ActivPAL	3 months
Secondary	Blood pressure	Change in blood pressure	3 months
Secondary	Depressive symptoms	Change in depressive symptoms, measured with Center for Epidemiologic Studies Depression (CESD) short form. Scores greater than 10 indicate probable depressive symptoms.	3 months
Secondary	Improvement in Quality of Life	Change in quality of life, measured with the EURO-QOL 5-D, a brief 5 item standard scale that has demonstrated validity in populations with diabetes and cardiovascular diseases.	3 months
Secondary	Anthropometrics	Change in body mass index (BMI)	3 months
Secondary	Psychosocial and environmental mediators: benefits and barriers	Investigators will use measures adapted for our pilot that include benefits and barriers to sitting less.	3 months
Secondary	Psychosocial and environmental mediators: self-efficacy	Investigators will use measures adapted for our pilot including self-efficacy to sit less.	3 months
Secondary	Psychosocial and environmental mediators: social support	Investigators will use measures adapted for our pilot including social support surrounding sitting less.	3 months
Secondary	Psychosocial and environmental mediators: home environment support	Investigators will use measures adapted for our pilot including home environment support surrounding sitting less.	3 months
Secondary	Psychosocial and environmental mediators: habit formation	Assessed using the Self-Report Habit Index	3 months
Secondary	Demographic moderators: age	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.	3 months
Secondary	Demographic moderators: sex	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.	3 months
Secondary	Demographic moderators: education	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.	3 months
Secondary	Demographic moderators: marital status	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.	3 months
Secondary	Demographic moderators: retirement status	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.	3 months